1. Field of Invention
The invention relates to vacuum constriction devices and therapy for erectile dysfunction treatment and augmenting male potency.
2. Description of Prior Art.
The acceptance of a vacuum constriction therapy has dramatically changed during the last decade. Considered as a doubtful 10-12 years ago, nowadays it is recognized as the first line remedy, preferable to other treatments of erection dysfunction--sex therapy, self injections, venous and arterial surgery, implantation of a penile prosthesis. With the vacuum constriction device sex function can be returned to its original state, bypassing many psychological problems. Numerous studies and surveys show that vacuum constriction therapy can help patients to improve sexual satisfaction, decrease psychiatric symptomatology, increase self-esteem. (Roy Witherington, "Suction Device Therapy in the Management of Erectile Impotence", Urologic Clinics of North America v. 15, No. 1, February 1988); D. E. Price et al. "The Management of Impotence in Diabetic Men by Vacuum Tumescence Therapy", Diabetic Medicine, 1991; 964-967). W. Meinhardt et al. "The Negative Pressure Device for Erectile Disorders: When Does It Fail?"; Journal of Urology, v. 149, p.p. 1285-87, May 1993.)
Presently manufactured vacuum constriction devices comprise a vacuum chamber with an open end serving as an entrance, a closed end connected to a vacuum pump through a hose, and constriction rings placed on the vacuum chamber close to its open end. To achieve an erection the penis is inserted into the open end of the vacuum chamber which is pressed to abdomen to provide an airtight seal. Then the vacuum is generated in the chamber with the manually or electrically operated vacuum pump. The partial vacuum inside the chamber causes the blood flow into the penis thus producing erection. To sustain the erection the constriction ring preliminary installed on the vacuum chamber is forced to slip off onto the root of the penis. Being placed on the root of the penis the constriction ring inhibits the blood flow from the penis thus sustaining erection. After this the vacuum is released, the chamber is removed from the erect penis.
In addition to listed major components, a vacuum constriction device may have auxiliary components or assemblies to facilitate constrictor's placement onto the vacuum chamber and dislodging them, appliance for equalizing pressure inside and outside the vacuum chamber after dislodging of constrictor, vacuum gauge etc.
Besides benefits listed above, existing vacuum constriction devices have substantial drawbacks and deficiencies which make them unacceptable to many users.
The most often drawbacks and reasons for rejection of known vacuum constriction devices are: pain, technical difficulties, inhibition of sexual behavior, painful placing of constriction rings and painful removal, insufficient erection, pivoting, blocking of ejaculation. (H. J. E. J. Vrijhof and K. P. J. Delaere "Vacuum Constriction Devices in Erectile Dysfunction: Acceptance and Effectiveness in Patients With Impotence of Organic or Mixed Aetiology", British Journal of Urology, 1994, 74, 102-105; S. Althof et al. "Through the Eyes of Women: The Sexual and Psychological Responses of Women to Their Partner's Treatment With Self-Injection or External Vacuum Therapy", The Journal of Urology, v. 147, 1024-1027, April 1992; Louisa A. Turner and associates "Treating Erectile Dysfunction With External Vacuum Devices: Impact Upon Sexual, Psychological and Marital Functioning", The Journal of Urology, v. 144; 79-82; 1990.
To make vacuum constriction therapy acceptable to users at large, substantial changes and improvements have to be introduced into comercially available devices.
Major inconveniences and deficiencies of prior art devices stem from their design features, methods of airtight sealing, constriction, method of simultaneous release of vacuum. Problems of design and function pertinent to prior art are discussed below.
Abdominal seal
In commercially available vacuum constriction devices the airtight seal is provided by pressing the open end of the chamber against the abdomen. In this case the scrotal tissue is encircled by vacuum chamber from very beginning and as soon as the negative pressure is applied the scrotal tissue is pulled into the chamber. It could be painful and even dangerous especially if the testicle is drawn in.
Penile airtight seal around the penis substantially reduces chances of suction of the scrotal tissue and testicle into the chamber. An air tight seal removably attached to the vacuum chamber is disclosed in Swiss Patent of Jun. 30, 1960 to G. Meldi. An elastic membrane with peripheral border which is folded over the vacuum chamber has a short sleeve in the center defining the orifice which corresponds to that of a flaccid penis so that it is not squeezed when being introduced into the chamber. There are significant drawbacks in such air tight seal:
a) as there must be a clearance between the orifice and the flaccid penis, the device has to be pressed against the abdomen, i.e. the seal is abdominal. Only after creation of vacuum and engorgement of the penis the sleeve functions as a penile seal, PA1 b) the membrane cannot be used with vacuum chambers which do not have protruding lips or flanges for folding membrane's peripheral borders over them. Such lips and flanges would hinder the transfer of constrictors from vacuum chamber, PA1 c) because of its complex shape, fabrication of Meldi's membrane require expensive molding equipment which greatly increases device's cost, PA1 d) in Meldi's device the diameter of the orifice has to be larger and correspond to that of the flaccid penis to prevent squeezing during its introduction into the chamber. According to the Kinsey Institute of Sex Research penile diameters are in a range from 1.2 to 5.4 cm. To provide membranes with sleeves' diameters corresponding this range of penile diameters will require a plurality of molds which will make production prohibitively expensive. PA1 1. placed directly on erect penis; PA1 2. placed on flaccid penis with inducing erection after placement; PA1 3. preliminary placed on vacuum chamber and forced to slip off on a root of erect penis.
Meldi's device does not have a separate constriction device. The same sleeve of Meldi's membrane functions as a constrictor. The deficiencies of this approach will be discussed further.
Vacuum devices with airtight seals around the penis capable to accommodate wider range of penile girths are disclosed in U.S. Pat. No. 5,125,890, Jun. 30, 1992 to D. Merill et. al.; U.S. Pat. No. 5,243,968, Sep. 14, 1993 to Kyoung Byun. Diaphragms described in these patents are permanently attached to the vacuum chamber with special provisions to prevent their detachment.
In a Merill et al. patent, (reference numerals in parenthesis) the sealing diaphragm (7) is formed from elastic tubing approximately 7.5 cm long, 2.5 cm in diameter and 0.1 cm wall thickness. The tubing is stretched over the outside wall of the chamber so that it firmly grips the chamber's wall. The grip of the stretched tubing actually has to be stronger than the grip of at least two constriction rings placed over it, so that during dislodging of constrictors the diaphragm will not slip off.
These are the conditions determining that according to specification the wall thickness of the tubing has to be at least about 0.1 cm. Because of substantial force needed to extend the diaphragm, a special skills and tooling are required. The user cannot reinstall or replace the diaphragm in case of a damage or slip off.
While providing benefits of a penile seal diaphragm mentioned above, a diaphragm disclosed in Merill's patent has substantial drawbacks associated with the requirements of a firm grip to prevent slip off from the vacuum chamber.
Dislodging with simultaneous vacuum release facilitates quick and easy removal of the vacuum chamber from erect penis. Vacuum release must be simultaneous with dislodging. The tumescence disappears immediately with releasing of vacuum unless the base of the penis is constricted. (W. Diderichs et al. "The effect of subatmospheric pressure on the simian penis", The Journal of Urology, 142, 1087-1089, 1989).
Known in prior art solution provide valves or holes which become automatically open during dislodging of constricting device.
R. Yanuck (U.S. Pat. No. 4,753,227, Jun. 28, 1988) provides mechanism which actuates a spring loaded arm with the sealing plug. The construction involves a plurality of small precise parts, fabrication and assembling of which increase device's cost. The mechanism enlarges the diameter of the vacuum chamber which complicates placement of the constriction device. Solutions without valves are disclosed in U.S. Pat. No. 5,244,453, Sep. 14, 1993 to Osbon and U.S. Pat. No. 5,338,288, Aug. 16, 1994 to E. Finkle. Osbon discloses a plurality of vent holes connecting interior of the vacuum chamber with the atmosphere. Holes formed in a groove perpendicular to the chamber's axis are covered by the constriction ring. Dislodging of the constriction ring opens the vent holes and releases vacuum in the chamber. It is difficult to keep all holes perfectly sealed by the constriction ring. Besides, the groove hinders constriction ring's movement off the chamber, the ring has to be extended to overcome groove's edge which may result in premature release of the vacuum.
In Finkle's patent only one vent hole is provided. This hole is covered by one of a turns of a multiturn constrictor band wound around the chamber. Again, as soon as this turn shifts, vacuum may be released prematurely.
Merill's (supra) patent also provides a function of simultaneous dislodging of constriction device and automatic releasing of vacuum.
The vacuum chamber and penile seal diaphragm have air holes (38), (40), a constriction band dislodging strap (36) has a plug (42), attached under its surface so that it enters and seals air holes. The constriction band (8) is positioned over the strap (36) with attached plug (42) to hold the plug firmly in air holes (38), (40). An upward pull of the strap draws plug from air holes and relieves the vacuum in the chamber while simultaneously dislodging constriction band (8). The air holes, the plug and the placement of the constricting band has to be precisely aligned which is difficult. The slightest displacement or deformation of diaphragm's air holes or plug or position of the constriction band will disturb air tightness with deterioration of vacuum.
Constriction device
No other part or component influences more on efficacy of a vacuum erection system than constriction device. Recognition of this problem is reflected in numerous surveys, reports and patents for improvements of constriction devices.
Prior art constriction devices may be subdivided into three major functional groups:
Constriction devices of group 1 are disclosed in U.S. patents as: U.S. Pat. Nos. 5,421,324; 5,370,601; 5,327,910; 5,246,015; 5,221,251; 5,085,209; 4,967,738; 4,834,115; 4,203,432; 3,773,040; 3,759,253; 2,581,114 and others. There is no provision in devices' designs for the use with vacuum chambers. Because of the limited use of constriction devices of this group we do not review them in detail.
Constriction devices of group 2 are unitary members combining function of a seal and a constriction device. These devices may be subdivided into three subgroups, depending on how the constriction is produced.
Subgroup 2a
In Meldi's device (Swiss patent No. 347 300, supra) diameter of constrictor's aperture is larger than diameter of flaccid penis. The constriction occures when engorging penis presses aperture from inside. With given diameter of the sleeve the only way to increase radial pressure is to augment engorgement by increasing degree of vacuum, which can be dangerously excessive. Penile engorgement is limited by individual user's anatomy. With existing range of penile diameters from 1.2 to 5.4 cm (Kinsey Institute of Sex Research, supra) a substantial number of membranes with different diameters has to be provided to select one which fits the individual user's anatomy.
In subgroup 2b a constrictor has a collar with aperture smaller then cross section of a flaccid penis. It is placed on the flaccid penis after which a vacuum erection device is applied and activated to achieve erection. The constrictor has a skirt large enough to cover the entrance of the vacuum tube and to provide airtight seal. The penis is pulled through the aperture so that the device is placed on a penile root, a vacuum chamber is applied and constriction is produced by penile engorgement. Examples of this subgroup are disclosed in U.S. Pat. No. 5,344,389, "Combination Seal and Constriction Device", Walsdorf et al. Sep. 6, 1994; U.S. Pat. No. 5,234,402, "Apparatus and Method for Augmenting Male Potency With User Tissue Protection", James B. Osbon, Aug. 10, 1993.
The device of Walsdorf et al. comprises a cylindrical collar with radially extending skirt, concentrical to the collar. The device is applied to the user's penis with the aid of the applicator assembly. A plurality of devices with different diameters of collars has to be provided to select one to accommodate erect penile size of a particular user. External vacuum erection chamber has to be held and pressed against the skirt all time during operation to avoid deterioration of vacuum.
The device of James B. Osbon (U.S. Pat. No. 5,234,402) has analogous deficiencies.
Constriction devices of subgroup 2c use inflatable ring encircling the penis. Inflatable constriction devices working with vacuum chambers are disclosed in U.S. Pat. Nos. 4,641,638, "Sexual Erection Prosthesis and Method of Use", Robert D. Perry, Feb. 10, 1987; 3,820,533 "Surgical Device with Suction Means", Jones, Aug. 2, 1971;
Inflatable constriction devices have an advantage in providing smooth control of pressure exerted on erect penis and rapid release of constriction when needed. To direct pressure inward they must have a hard shell, which limits contacting part of the penis and can hurt female partner during penetration.
Devices of group 3 are disclosed in U.S. patents: U.S. Pat. Nos. 5,338,288 "Noninvasive Male Potency Device", Eugene Finkle, Aug. 16, 1994; 5,195,943, "Male Organ Restrictor Ring Applicator", John Chaney, Mar. 23, 1993; 5,125,890 "Vacuum-Constriction Erection Aid Device", D. S. Merill et al. Jun. 30, 1992 (supra); 5,115,800, "Apparatus for Achieving and Maintaining Penis Erection", Matejevic et al.; 5,095,895, May 26, 1992, "Negative Pressure Erection Apparatus", Michael Walsh, Mar. 17, 1992; 5,083,556, "Penile Cincture Band Operational Apparatus", Osbon et al., Jan. 28, 1992; 4,856,498, "Vacuum Generating and Constriction Apparatus", Osbon et al., Aug. 15, 1989; 4,856,499, "Erection Device", Edward C. Kelly, Aug. 15, 1989; 4,753,227, "Erection Device and Method", Rudolph R. Yanuck, Jun. 28, 1988; 4,741,329, "Surgical Appliance for Stimulating an Erection", Benjamin F. Marcune, May 3, 1988 4,539,980 "Male Organ Conditioner", John L. Chaney, Sep. 10, 1985; 4,378,008, "Erection Aid Device", Gedding Osbon, Mar. 29, 1983; 3,744,486 "Apparatus for Obtaining an Artificial Erection" Eldon M. Wilson, Jul. 10, 1973.
Constrictors used in known vacuum constriction devices generally comprise a ring of elastic rubber with C-shaped handles for removal from the erect penis. Detailed descriptions of constriction rings are disclosed in U.S. Pat. No. 5,306,227, "Apparatus for Augmenting Male Potency", to Robert and James Osbon on Apr. 26, 1994 and U.S. Pat. No. 4,539,980, "Male Organ Conditioner", to John L. Chaney on Sep. 10, 1985 (supra). To provide sufficient inward pressure on erect penis, one or more of constriction rings have to be placed at the edge of an open end of the vacuum chamber. Placing the ring on the edge of the vacuum chamber requires strong fingers and dexterity, many of users do not have. Recognizing this problem, special cone-shaped applicator have been proposed. (U.S. Pat. No. 5,083,556, "Penile Cincture Band Operational Apparatus", to Osbon et al. on Jan. 28, 1992; U.S. Pat. No. 5,020,522 "Compact Vacuum Therapy System", to Edward T. Stuart on Jun. 4, 1991; U.S. Pat. No. 4,539,980 (supra); "Male Organ Conditioner Accessory", to John. L. Chaney on Dec. 16, 1986).
Accessories and apparatus facilitate the problem, but complicate the device and increase its cost. Device for transfering of a constriction ring is disclosed in U.S. Pat. No. 5,195,943 "Male Organ Restrictor Ring Applicator", to John L. Chaney on Mar. 23, 1993 uses moving and fixed cam elements on the vacuum chamber.
Disclosed in U.S. Pat. No. 5,115,800 "Apparatus For Achieving and Maintaining Penis Erection" to Matejevic et al. on May 26, 1992 (supra) uses mechanism of lever and belt, making vacuum erection device mechanically complicated and substantially increasing dimensions and cost.
Complains on pain are often caused by imperfection of constriction rings. Rings are molded of natural or synthetic rubber with different durometer number. To provide acceptable inward pressure, selection for individual users is based on size, durometer and a number of constriction rings used together. Despite high cost due to a number of expensive molds, there is no way to provide smooth control of the pressure which happens to be excessive and causes discomfort, numbness, bruises.
Discomfort and pain can also be caused by twisting of doubled rings during their transfer onto the penis and because of intertwining with pubic hair. Removal of constriction ring from erect penis could be painful, especially when two or more rings are used together; after removal of the first ring the penis is still engorged, as the remaining ring prevents blood outflow.
Known are in prior art linear elastomeric constrictors wound around vacuum chamber.
U.S. Pat. No. 3,744,486 "Apparatus for Obtaining an Artificial Erection", to Eldon M. Wilson on Jul. 10, 1973 (supra) discloses an elastic restrictor mounted tightly upon the exterior surface of the entrance tube. There is no teaching in the disclosed text about the key features of the multiturn constrictor, particularly, how the constrictor is kept in a tightened condition after wrapping around the chamber and how it is released from erect penis.
U.S. Pat. No. 5,338,288, "Noninvasive Male Potency Device" to Eugene Finkle on Aug. 16, 1994 (supra) discloses a constrictor device, which is a length of elastomeric material with knots near each end. The constrictor is initially wound around a vacuum cylinder with a plurality of turns, and the distal knotted end is tucked underneath the proximal knotted end. For removal, the constrictor has to be pulled on eather end.
This approach has advantage in increased safety against excessed pressure as the device allows a gradual pressure variations. But there are also serious drawbacks: during transfer from the vacuum cylinder turns are twisting and pinch skin and pubic hair. But the strongest pain is during unwrapping of the constrictor and return to its original unstretched size. Individual turns of constrictor abruptly change their cross section and length with pinching of penile skin and producing painful sawing action.
Pivoting is another deficiency inherent to all known vacuum constriction devices. In prior art constriction rings the inward radial pressure is applied to a narrow annular surface of the penis. Retaining the blood in the sponge bodies, constriction rings keep the penis engorged. The sponge bodies between the penile root and the ring are filled much less because of blood outflow. This causes pivoting--an engorged penis behaves as attached by hinges, which eventually presents the mayor difference between natural erection and one maintained with the use of constriction device.